Catheters and manipulators with articulable ends

ABSTRACT

The disclosure provides various embodiments of catheters having articulable ends that can be used for various procedures. Embodiments of methods are also provided that can be performed with catheters in accordance with the present disclosure.

CROSS-REFERENCE TO RELATED APPLICATION

This patent application is a continuation-in-part of and claims thebenefit of priority to International Patent Application No.PCT/US18/48177, filed Aug. 27, 2018, which in turn claims the benefit ofpriority to U.S. Provisional Application Ser. No. 62/550,347, filed Aug.25, 2017, U.S. Provisional Application Ser. No. 62/567,203, filed Oct.2, 2017, U.S. Provisional Patent Application Ser. No. 62/663,518, filedApr. 27, 2018, U.S. Provisional Application Ser. No. 62/688,378, filedJun. 21, 2018, and U.S. Provisional Patent Application Ser. No.62/712,194, filed Jul. 30, 2018. The present application also claims thebenefit of priority to U.S. Patent Application Ser. No. 62/728,413,filed Sep. 7, 2018. Each of the foregoing patent applications isincorporated by reference herein in its entirety for any purposewhatsoever.

FIELD

The disclosure relates generally to medical treatment devices andtechniques, and, in some aspects, to methods and devices for diagnosisand treatment of cardiac valves.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A-1D are illustrations of a first device in accordance with thepresent disclosure.

FIGS. 2A-2D are illustrations of a second device in accordance with thepresent disclosure.

FIGS. 3A-3C show aspects of a first embodiment of a guide wire used inan electrosurgical procedure in accordance with the disclosure.

FIG. 4 shows aspects of a second embodiment of a guide wire used in anelectrosurgical procedure in accordance with the disclosure.

FIGS. 5A-5B present views of a grasping catheter or manipulator inaccordance with the present disclosure.

FIG. 5C presents a further embodiment of a grasping catheter inaccordance with the present disclosure.

FIG. 6 illustrates a cross sectional view of an extruded main bodyportion of an illustrative catheter in accordance with the disclosure.

FIGS. 7A-7D present various embodiments of a dual lumen catheter inaccordance with the present disclosure.

FIG. 8 presents the embodiment of FIG. 7A including a snare catheterdisposed through the minor lumen for effectuating capture, for example,of a guidewire in a medical procedure.

FIGS. 9A-9B illustrate an articulating catheter having two preformedbends that resume their bent shape when advanced distally from the maincatheter.

FIG. 10 illustrates an illustrative cross section of a catheter inaccordance with the present disclosure.

FIGS. 11A-11C present various views of a further embodiment of acatheter in accordance with the present disclosure.

FIGS. 12A-12E present views of still a further catheter in accordancewith the present disclosure.

FIGS. 13A-13C present views of a procedure using the embodiment of FIGS.12A-12E with respect to the anatomical structure of a tricuspid valve.

DETAILED DESCRIPTION

For purposes of illustration, and not limitation, exemplary embodimentsof a catheter, which can also be used as a robotic manipulator, arepresented in FIGS. 1A-1D and 2A-2D. For purposes of simplicity but notlimitation, the devices are typically referred to herein as “catheters”but it will be understood by those of skill in the art that they canequally be considered to be robotic manipulators.

With reference to FIGS. 1A-1D, an elongate catheter is provided having aproximal end and a distal end. The catheter includes an elongate tubularmain body 22 having a proximal end, a distal end, and defining at leastone elongate passage therethrough. The elongate tubular main bodydefining a longitudinal axis along its length.

The catheter includes a first elongate inner body 10 having a proximalend and a distal end. The inner body 10 is illustrated with anillustrative cone-shaped atraumatic distal tip 24 that is configured tospread applied stress out over a larger area, which can be of particularbenefit when contacting delicate anatomical structures. The firstelongate inner body 10 is slidably disposed within the at least oneelongate passage of the elongate tubular main body 22.

Also illustrated is a second elongate inner body 20 having a proximalend and a distal end that is slidably disposed within the at least oneelongate passage of the elongate tubular main body 22, which is suitablyconfigured to maintain registration of bodies 10 and 20 with respect toeach other and hold them together. Bodies 10 and 20 can be housed in acommon passage, or in individual passages defined within body 22. Body20 is slidably disposed with respect to the first inner body 10, whereinan exposed distal region 26 of body 20 is illustrated as protrudingbeyond the distal end of main body 22.

As illustrated, the distal end of the first and second inner elongatebodies 10, 20 are preferably biased or otherwise configured to be curledor steered away from the longitudinal axis in a proximal direction whenthe first elongate inner body is advanced distally with respect to themain body by virtue of inner body 10 being removed from body 22. Bodies10, 20 can be configured to curl as illustrated when advanced distallyfrom body 22 by making bodies 10, 20 at least in part from shape memorymaterials, and/or by utilizing a steering wire that travels the lengthof the body 10, 20 that is attached to a distal end of each of thebodies 10, 20, such as by way of a ring (e.g., a radiopaque marker band)that is attached to the distal end of the bodies. In another embodiment,one or more of bodies 10, 20 can be formed at least in part bythermoplastic or other polymeric or composite material that is moldedwith a preformed bend therein. Such a pre-bent or pre-formed body 10, 20can then be loaded, for example, into main body 22, wherein main body 22maintains the bodies 10, 20 in a straight orientation until they bodies10, 20 are advanced distally with respect to main body 22, at which timethey revert to their curved shape and regain at least some of theiroriginal curvature.

Main body 22 can simply be an overwrap or a sheath in someimplementations that functions to maintain the bodies 10, 20 in aparallel relationship and optionally maintains the bodies 10, 20 in arelative orientation until the bodies 10, 20 are advanced distally withrespect to body 22. In other implementations, body 22 can be moresophisticated such as a multi-lumen extrusion including a plurality oflumens for slidably containing bodies 10, 20, and other devices, asdesired. In lieu of a main body 22 or overwrap, bodies 10, 20 canalternatively be fused or adhered to each other, or be provided with anadjustable coupling that runs their lengths that permits relativeslidability of bodies 10, 20. For example, body 10 can be provided witha rib along the majority of its length (e.g., except for the distal most5-10 cm) having a “T”-shaped cross section, wherein the base of the Tadjoins the body 10, and body 20 can be provided with a “C”-shapedchannel along its length that slidably receives the T-shaped rib.

If desired, each of the first elongate inner body 10 and second elongateinner body 20 can each define one or more lumens along their respectivelengths. The lumen(s) can be used, for example, for passage of a furthermedical instrument such as a guidewire or viewing scope, for directingelectrical conductors, and the like, and/or for passage of a steeringwire along the length of body 10, 20 terminating, for example, in amarker band at the distal end of body 10, 20 that the steering wireattaches to. Other examples of suitable steering mechanisms can be foundin U.S. Pat. Nos. 6,030,360, and 6,579,278, which are incorporated byreference herein in their entireties for any purpose whatsoever. Eitherbody 10, 20 if equipped with such a passage can additionally oralternatively include a movable body (e.g., core wire, snare catheter,etc.) slidably disposed therein.

If the passage within body 10 includes a snare catheter (such as thatdescribed in U.S. patent application Ser. No. 13/824,198, filed May 1,2013, which is annexed to U.S. Provisional Application Ser. No.62/567,203, filed Oct. 2, 2017, as US2013/0211510, and is expresslyincorporated by reference herein for any purpose whatsoever), the snarecatheter can be directed out of the distal end of body 10 to provide alanding or target zone for a guidewire that is directed through thedistal end of body 20 (not shown). This permits a guidewire thattraverses through the distal end of the body 20 to be captured by thesnare catheter that extends outwardly from body 10, thereby permittingthe guidewire extending from the distal end of body 20 to be pulled intothe distal end of body 10, and advanced through the body 10 andexternalized or otherwise directed out of the proximal end of body 10(not shown).

If desired, the guidewire disposed in body 20 can include anelectrically conductive core wire surrounded by a jacket made fromdielectric/insulating material. The jacket can be removed from a portionof the core wire to expose a portion of the core wire. In a furtherembodiment, as illustrated in FIGS. 3A-3C, the guidewire can include acore wire that is in turn surrounded by a first insulating layer. Asillustrated in FIG. 3A, the guidewire 300 can have an electricallyconductive core wire 320 surrounded by a jacket 320 made from dielectricmaterial, such as PTFE or other suitable material. The jacket can bestripped off on one side to create an exposed region 330 of the corewire 320. The ends of the core wire 320 can likewise be exposed, and thewire can be bent in half so that the exposed core wire 320 faces itself.When the exposed ends 340 of the core wire 320 are then connected to agenerator (not shown) in a bipolar arrangement in this case to causecurrent to pass through the core wire, in the exposed region of the corewire that is bent over, an electrical discharge, or arc, can developthat jumps across the gap (rather than the current passing only alongthe core wire) that can be used to help cut and/or burn through tissueby pulling the exposed wire through the tissue.

If desired, the guidewire can be provided with more than one conductinglayer as embodiment 400 in FIG. 4. Guidewire 400 has an exposed proximalend 402 connected to a distal tip (in this case in the shape of ametallic ball 404, and an elongate core wire 406. A first insulatinglayer 408 (made of a polymeric layer, for example), is disposed aboutthe core wire 406 along its length, but leaving the tip 404 and proximalend 402 exposed. Proximal end 402 can be electrically coupled to asignal generator, and the current can pass, for example, through thedistal tip 404 and follow a return path to a conductive path (not shown)through the patient's body (monopolar arrangement) to the electricalgenerator. This is a useful arrangement for cutting through tissue withthe tip of the guidewire 400. If desired, a beneficial agent may beinjected through one or more arms of the system to the cutting site,such as nonionic 5% dextrose, in order to reduce the non-targetconduction and enhance to laceration. Guidewire 400 further includes asecond electrical conductor, or conducting layer, 410, is disposed atleast partially about, or at least radially outwardly from, the firstinsulating layer 408. The second electrical conductor/conducting layer412, in turn, can in turn be surrounded by an outer insulating layer420. The outer insulating layer can be removed to expose a portion ofthe second electrical conductor/conducting layer to define an exposedportion 424 of the second electrical conductor/conducting layer. Asillustrated, portion 424 is facing laterally outwardly to permit a cutto be performed by moving the guidewire 400 laterally to the side, whena proximal end of the layer 410 is attached to a signal generator.Current then flows through the exposed portion 424 and through thetissue to a conductive pad that is attached to a return path of thesignal generator. Conductive layer 410 can be a continuous layer, suchas a tubular layer, or can be an interrupted layer, wherein a conductivepath is nonetheless maintained from the exposed patch 424 to theproximal end of the conductive layer 410.

Conductive layer 410 can be formed, for example, from a metallic tube,such as a hypotube, in turn be defined by a tubular body that defines atleast one opening 422 therethrough. For example, the at least oneopening can be spiral shaped (via laser cutting) and winds around thefirst insulating layer, resulting in the remaining conductive materialalso winding around the first insulating layer. Alternatively, the atleast one opening and the tubular body define a plurality ofarticulating segments, similar to those defined in U.S. Pat. No.8,530,783, Feb. 3, 2010, U.S. Pat. No. 5,605,543, filed Jan. 30, 1996,U.S. patent application Ser. No. 10/969,088, filed Oct. 20, 2004, orWO2017117092, each of which is incorporated by reference herein in itsentirety for any purpose whatsoever and appended to U.S. ProvisionalApplication Ser. No. 62/567,203, filed Oct. 2, 2017.

The disclosure also provides an electrosurgical system including a radiofrequency power supply (such as that described in U.S. Pat. No.6,296,636, which is incorporated by reference herein in its entirety forany purpose whatsoever and annexed to U.S. Provisional Application Ser.No. 62/567,203, filed Oct. 2, 2017) operably coupled to the electricallyconductive core wire of the elongate catheters (and/or of the secondconductors of catheters) disclosed herein. Thus, the radio frequencypower supply can be operably (and selectively) coupled to theelectrically conductive core wire and to the second electricalconductor, as desired. Similarly, the disclosure also provides anultrasonic surgical system, such as an ultrasonic scalpel, including anultrasonic power source, such as that disclosed in U.S. Pat. No.6,514,267, which is incorporated by reference herein in its entirety forany purpose whatsoever.

In further embodiments, and with reference to FIGS. 5A-5B, the body(e.g., 20) of the catheter can be configured so as to penetrate ananatomical structure, such as a heart valve leaflet 475, prior topassing into the lumen of the first elongate inner body. Tip(s) 24 ofthe catheter can grip the leaflet and align the passages in the arms ofthe catheter to permit a guidewire (e.g., 300, 400) to pierce theleaflet and pass through the catheter arms. Piercing can be accomplished(preferably under imaging, such as fluoroscopy) with a sharpened tip andcuff connection, electrosurgical or ultrasonic cutting tip (e.g., 404).Typically, the leaflet (e.g., 475) is penetrated or pierced in a regionthat is near or in the annulus 485 of the valve leaflet, most preferablywhere the annulus transitions to the leaflet base. The disclosedembodiments can be used to perform the procedures described in thejournal publications annexed to U.S. Provisional Application Ser. No.62/567,203, filed Oct. 2, 2017, which is incorporated herein byreference as set forth above (Khan 2016, Babaliaros 2017). When anelectrically exposed portion of the guide wire is in alignment with theleaflet, the ends of the catheter can be withdrawn partially, theelectrical current can be turned on, and the exposed portion of theguidewire can be pulled through the leaflet, cutting the leaflet.

This procedure for cutting the leaflet can be used in support of avariety of procedures where it is useful to cut a valve leaflet. Forexample, it can be very useful to perform such a cutting procedure forclearing space for a replacement valve, such as a replacement, mitral ortricuspid valve. The valve leaflets can be cut accordingly making spacefor a replacement valve to be installed in any desired manner. Moreover,such cutting methods can be used to remove other structures that are nolonger desired in the anatomy. For example, if an Alfieri stitch, or aclip, is used to attach a portion of two leaflets to each other, thedisclosed embodiments can be used to cut through one or both of theleaflets to free them from each other, and to also prepare the site, ifdesired, for a replacement valve, such as by forming one or moreadditional cuts in each native leaflet, and/or removing a portion of, orsubstantially the entirety of, or the entirety of, one or more of thenative leaflets. If desired, all the leaflets can be removed, and anystructures attached thereto (e.g., chordae) can also be cut and/orremoved. In some implementations, a suture or clip (e.g., a MitralClip)can be removed from a patient's mitral valve, after which furthertherapeutic steps can be performed including repair of the valveleaflets, reshaping of the valve leaflets, removing all or a portion ofone or all leaflets, or cutting the leaflets and any chordae out of theway, as desired, to make room for a replacement valve.

Similar procedures for resecting or cutting tissue anywhere in the bodycan be used by utilizing devices and methods in accordance with thepresent disclosure. Such procedures can be used for cutting valveleaflets, for example, in any of the cardiac valves, any valves inveins, such as the IVC, or for cutting any other anatomical structuresin the body.

Any suitable power level and duty cycle can be used in accordance withthe disclosed embodiments. For example, continuous duty cycle (cutting)radiofrequency (“RF”) energy can be used, for example, at a power levelbetween about 50 and 100 Watts, or any increment therebetween of aboutone watt. The cuts can be made by applying power for between about onehalf of a second and about five seconds, or any increment therebetweenof about one tenth of a second.

FIG. 5C presents an alternative embodiment of a grasping catheter 500that can be used in place of a pair of catheters simply for grasping theedge of a leaflet 475. The catheter 500 includes a tubular outer body510 having a proximal end, a distal end and a longitudinal passagetherethrough. An internal slidable gripping mechanism is slidablydisposed within the lumen of outer body 510 that includes a proximalactuator or handle 502 that is connected to an elongate inner body 518that separates at a bifurcation 516 into a first arm 512 and a secondarm 514, that in turn terminate in inwardly pointed gripping ends 524,526. Arms 512, 514 are biased away from each other, and can be urgedtogether by withdrawing the arms and accompanying tips toward the distalend of the tubular member 510. Accordingly, by controlling the relativeplacement of the inner mechanism and outer tube, the jaws formed by arms512, 514 and gripping ends 524, 526 can be opened and closed. Catheter500 can be used as a sub-catheter in any embodiment herein.

As a further example, the movable body (e.g., 20, or a slidable devicewithin a lumen defined by body 20) can include a dart passer that isconfigured to advance a dart having a suture attached thereto out of thedistal end of the second elongate inner body and into a receiving cuffdisposed in the lumen of the first elongate inner body, in accordancewith the teachings of US2013/0310853, which is incorporated by referenceherein in its entirety for any purpose whatsoever. For example, thereceiving cuff can be disposed within a lumen defined in body 10 at isattached to a filament/suture that passes through the lumen of body 10that can receive a dart attached to or resting on the distal end of ahypotube that is advanced through body 20, wherein the dart has atrailing suture that passes through the body of the hypotube. Afterconnecting the dart and cuff, the suture attached to the cuff or thesuture attached to the dart can be advanced withdrawing the couplingfrom the patient, and leaving behind the looped suture.

In accordance with further aspects, the rotational position of the firstelongate inner body 10 can be fixed with respect to the rotationalposition of the second elongate inner body 20. Or, if desired, therotational positions of each of body 10 and 20 can be controlled by auser at a control actuator/Luer lock at a proximal location of thecatheter.

In accordance with further aspects, and as presented in FIGS. 2A-2D, thecatheter can further include a third elongate inner body 30 having aproximal end and a distal end that is slidably disposed within the atleast one elongate passage of the elongate tubular main body, the distalend of the third inner elongate body being biased (or otherwiseconfigured, e.g. via steering wire) to curl away from the longitudinalaxis in a proximal direction when the third elongate inner body isadvanced distally with respect to the main body. If desired, thecatheter can further include a fourth elongate inner body 28 having aproximal end and a distal end that is slidably disposed within the atleast one elongate passage of the elongate tubular main body, andslidably disposed with respect to the third inner body. The distal endof the fourth inner elongate body 28 can be biased or otherwiseconfigured to curl away from the longitudinal axis toward the proximallyoriented distal end of the third elongate inner body 30 when the fourthelongate inner body is advanced distally with respect to the main body.Any suitable number of such inner bodies can be provided, depending onthe procedure being performed.

As with the embodiment of FIGS. 1A-1D, the third elongate inner body 30and fourth elongate inner body 28 can define a lumen along theirlengths. The lumen of the fourth elongate inner body 28 can include adevice as described elsewhere herein (guidewire, snare catheter)slidably disposed therein having a distal end that is configured to bereceived by the lumen of the third elongate inner body at the proximallyfacing distal end of the third elongate inner body.

Each of bodies 10, 20, 22, 28, 30 can be made from a variety ofmaterials, including multilayer polymeric extrusions, such as thosedescribed in U.S. Pat. No. 6,464,683 to Samuelson or U.S. Pat. No.5,538,510 to Fontirroche, the disclosure of each being incorporated byreference herein in its entirety. Other structures are also possible,including single or multilayer tubes reinforced by braiding, such asmetallic braiding material. Any of the catheters, manipulators,guidewires, or other catheters disclosed herein or portions thereof(e.g., portions 10, 20, 22, 28, 30) can be provided with regions ofvarying or stepped-down stiffness with length using any of thetechniques set forth in U.S. Pat. No. 7,785,318, which is incorporatedby reference herein in its entirety for any purpose whatsoever.

Preferably, the bodies 10, 20, 28, 30 have a decreased stiffness alongtheir length, particularly in their distal regions by adjusting thecross sectional dimensions of the material to impact stiffness andflexibility, while maintaining pushability, as well as the durometer ofthe material. Hardness/stiffness is described herein with reference toShore hardness durometer (“D”) values. Shore hardness is measured withan apparatus known as a Durometer and consequently is also known as“Durometer hardness”. The hardness value is determined by thepenetration of the Durometer indenter foot into the sample. The ASTMtest method designation is ASTM D2240 00, an example of which is annexedto U.S. Provisional Application Ser. No. 62/567,203, filed Oct. 2, 2017.For example, a more proximal region of the catheter can have a durometerof about 72D, an intermediate portion of the catheter (the proximal most20-30 cm of the last 35 cm, for example that typically traverses anaortic arch) can have a durometer of about 55D, and the distal 5-10 cmof the catheter can have a durometer of about 35D.

Any surface of various components of the system described herein orportions thereof can be provided with one or more suitable lubriciouscoatings to facilitate procedures by reduction of frictional forces.Such coatings can include, for example, hydrophobic materials such asPolyTetraFluoroEthylene (“PTFE”) or silicone oil, or hydrophiliccoatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are alsopossible, including, echogenic materials, radiopaque materials andhydrogels, for example.

One or more actuators can be provided to actuate relative proximal anddistal movement of bodies 10, 20, 28, 30 with respect to main body 22.Such actuators typically provide either two handles for push-pullactuation, or the actuator can be more exotic. For example, it is alsopossible to use other actuators as are known in the art, such asthreaded rotating actuators similar to those for retractable sheaths asdescribed in U.S. Pat. No. 6,488,694 to Lau and U.S. Pat. No. 5,906,619to Olson, the specifications of which are incorporated herein byreference.

With reference to FIGS. 3 and 4, the disclosure also provides a methodthat includes providing an electrosurgical system as describedhereinabove, deploying the distal end of the catheter into a patient'svasculature to a target location proximate the patient's valve,deploying the first elongate inner body so that the distal end of thefirst elongate inner body curls around the edge of the patient's valveleaflet, deploying the second elongate inner body so that the distal endof the second elongate inner body bends toward the distal end of thefirst elongate inner body, directing the guidewire out of the distal endof the second elongate inner body, through the patient's valve leafletnear the valve annulus (such as where the annulus transitions to thebase of the leaflet), and into the lumen of the first elongate innerbody, advancing the guidewire until the exposed portion of the core wireor second conductor is located in a gap defined between the distal endof the first elongate inner body and the distal end of the secondelongate inner body that coincides with the valve leaflet, wherein theexposed portion of the core wire is facing in a proximal direction,energizing the power supply of the electrosurgical system, and advancingthe exposed portion of the core wire or second conductor through atleast a portion of the valve leaflet to effectuate a cut in the valveleaflet.

As described herein, when practicing the illustrative methods, theexposed portion of the core wire or second conductor can be advancedthrough the valve leaflet through a peripheral edge of the valveleaflet. In some implementations, the valve leaflet can be a mitralvalve leaflet, such as a native or artificial/replacement anterior orposterior mitral valve leaflet, or a native or artificial/replacementtricuspid, pulmonary or aortic valve leaflet. It will be appreciatedthat the disclosed systems can be used with respect to any suitablenative or artificial/replacement valve leaflet.

The disclosure also provides a robotic manipulator having a proximal endand a distal end that includes an elongate tubular arm having a proximalend, a distal end, and defining at least one elongate passagetherethrough, the elongate tubular arm defining a longitudinal axisalong its length. The manipulator further includes a first elongateinner body having a proximal end and a distal end that is slidablydisposed within the at least one elongate passage of the elongatetubular arm, the distal end of the first inner elongate body beingbiased (or otherwise configured, such as pre-forming and/or steeringwire) to curl away from the longitudinal axis in a proximal directionwhen the first elongate inner body is advanced distally with respect tothe arm. The manipulator can further include a second elongate innerbody having a proximal end and a distal end that is slidably disposedwithin the at least one elongate passage of the elongate tubular armthat can be slidably disposed with respect to the first inner body. Thedistal end of the second inner elongate body can be biased to curl awayfrom the longitudinal axis toward the deployed proximally orienteddistal end of the first elongate inner body when the second elongateinner body is advanced distally with respect to the arm.

At least one of the elongate tubular arm, first elongate inner body orsecond elongate inner body can be connected to an axial actuator,wherein the actuator is configured to advance the component to which itis connected along a direction parallel to the longitudinal axis.Moreover, at least one of the elongate tubular arm first elongate innerbody or second elongate inner body can be connected to a rotationalactuator, wherein the rotational actuator is configured to rotate one ormore of the elongate tubular arm, first elongate inner body and secondelongate inner body.

At least one of the first elongate inner body and second elongate innerbody can include an end effector attached thereto configured to performat least one of a cutting, grasping, irrigating, evacuating, viewing orsuctioning function. If desired, the end effector can include one ormore of an electro surgical device, a blade, and an ultrasonictransducer.

The disclosure also provides implementations of a laparoscopic, urinary,gynecological, neurological, or orthopedic surgical procedure utilizingthe catheters or robotic manipulators disclosed herein. The disclosedcatheters/manipulators can also be used in any suitable minimallyinvasive procedure, or a percutaneous procedure.

For example, the percutaneous procedure can include utilizing one ormore of the disclosed devices to access a patient's sinus passages. Thedevices can be used, for example, to remove one or more polyps, and caneven be used to breach a thin bony layer within the sinuses to accessthe cranial cavity to perform a procedure inside the cranial cavity.

In other embodiments, the percutaneous procedures disclosed herein caninclude an ablation procedure, such as within the heart of a patient orelsewhere, as well as a cryoablation procedure. The disclosure alsoprovides suitable handles and actuators (illustrated in the Appendix ofU.S. Provisional Application Ser. No. 62/567,203, filed Oct. 2, 2017,for example) for controlling one or more of the first elongate innerbody, second elongate inner body and elongate tubular main body.

In further accordance with the present disclosure, FIG. 6 illustrates across sectional view of an extruded main body portion 600 of a furtherembodiment of a catheter. The body includes an extrusion defining twooffset channels 610, 620. A first channel 610 is illustrated as having agenerally circular cross-section, and the second channel 620 that isparallel thereto is illustrated as having a cross-section that iscircular with a scalloped portion removed in order to accommodate thechannel with the circular cross section. The main body 600 can be madefrom any suitable polymeric material, such as those set forth herein.The main body can be formed from a multilayer polymeric extrusion withone or more reinforcement (e.g. layers of braiding) formed thereon ortherein. The main body can be coated with any suitable coating ormaterial to enhance its lubricity, as desired.

FIG. 7A presents a side view of the illustrative catheter of FIG. 6including the main shaft 600 described above, provided with at least onebraided layer. The catheter further includes a distal tubular segmentextending distally from main shaft 600 that defines therein lumen 610that is radially co-located with the first channel of the main body. Forexample, the distal tubular segment can be an extruded tube that extendsthe full length along the inside of the main body to a proximal end ofthe catheter. The distal tubular segment may similarly be braided ifdesired, may be pre-curved as described elsewhere herein and/or can bedeflectable, for example, by providing a pull wire within the lumen ofthe distal segment, or within a co-extruded lumen of the distal segment(not specifically illustrated). A distal end of the pull wire (notshown) can be attached to a collar embedded within or on the distaltubular segment, as desired. As illustrated in FIG. 7B, the distaltubular segment and its associated channel that it surrounds can be usedto act as a guidewire lumen, permitting the catheter to be used as anover the wire catheter, or for delivering a lower profile cathetertherethrough, such as a snare catheter, as set forth in further detailbelow.

FIG. 7C illustrates an embodiment wherein the larger/major, e.g.,non-circular, lumen defined in the main body can act as a delivery lumenfor a catheter that can be steerable (e.g., by a steering wire) or thatcan have a curve preformed into it (e.g., by heating and bending thecatheter if polymeric in composition) that the catheter can assume afterit is advanced distally out of the distal end of the major lumen of themain body. As presented in FIG. 7D, the distal tubular segment can beprovided with a further tubular member disposed thereon, or integratedtherewith in a co-extrusion, that can act as a guidewire lumen tofacilitate a rapid exchange (“RX”) procedure with the guidewire ratherthan having the guidewire traverse the entire length of the catheter asin an over the wire (“OTW”) procedure.

FIG. 8 presents the embodiment of FIGS. 7A-7D, but including a snarecatheter 800 disposed through the minor lumen for effectuating capture,for example, of a guidewire in a mitral cerclage procedure as set forthin U.S. patent application Ser. No. 15/796,344, filed Oct. 27, 2017.Further aspects of the snare catheter can be seen in that application,as well as in U.S. Provisional Patent Application Ser. No. 62/615,309,filed Jan. 9, 2018. Each of the foregoing applications is herebyincorporated by reference for any purpose whatsoever. The presentcatheter can be used, for example, for such mitral cerclage procedures.For example, the snare catheter can be used to capture a guidewire whilethe major passage accommodates an articulating catheter as describedhereinabove for grasping a cardiac valve leaflet, or other structure.

A further embodiment is presented in FIGS. 9A-9B, which illustrates anarticulating catheter having two preformed bends that resume their bentshape when advanced distally from the main catheter. FIG. 10 illustratesa further possible cross section for the main catheter, wherein majorand minor lumens 1010, 1020 are presented, but two additional steeringwire lumens 1030 are presented. If desired, further steering wire lumensare presented that can be used for housing a pull wire that is attachedat its distal end to a portion of the catheter (not shown), such as to aring collar that is formed on or in the body of the catheter.

FIGS. 11A-11C display a further embodiment of a catheter in accordancewith the disclosure (or aspects thereof) that includes a scoop on one ofthe articulating arms as presented. The scoop, or funnel, can help guidethe other articulating arm into contact with it. If desired, permanentmagnets can be added at the end of each articulating arm (not shown), ora winding around each end of the catheter can be made to form a solenoidon the end of each of the arms (not shown). When electrical current isrun along the same helical direction through each solenoid, the createdmagnetic fields add to each other, and attract each other, causing thearms to move more closely together into contact. The force is directlyproportional to the current that passes through the windings. Alsoillustrated is a push-pull actuator for relatively articulating each ofthe deployable limbs in the catheter. The disclosed catheter uses atoothed wheel, or gear, that rotates around an axle and engages a gearrack in a sliding track that in turn is attached to one of thearticulating arms.

For purposes of illustration, and not limitation, FIGS. 12A-13C depictyet another embodiment of a catheter in accordance with the presentdisclosure.

FIG. 12 illustrates a further embodiment 1400 of a catheter. The distalend 1404 of catheter 1400 is depicted to highlight its functionality.Catheter 1400 also includes a proximal end and elongate body (not shown)having one or more actuators to manipulate the various sub-components ofcatheter 1400 described in detail below. Catheter 1400 is defined by anouter tubular member having a proximal end, a distal end 1404, anddefines an elongate passage therethrough along its length. Elongatepassage slidably accommodates an intermediate tubular member 1450therein having a proximal end (not shown), a distal end 1452 and in turnalso defining a passage along its length for slidably receiving asubassembly therein including at least one further catheter, tool ormanipulator. As illustrated in FIGS. 12A-E, a subassembly is providedslidably received within intermediate tubular member 1450 that includesa central tubular member 1410 having a proximal end, a distal end 1414,and defining a passage along its length, for example, for receiving aguidewire for guiding catheter 1400 to a target location. Asillustrated, central tubular member 1410 is a straight member, but canbe imparted with a curvature if desired. The subassembly furtherincludes a second tubular member 1420 having a proximal end (not shown),a distal end 1424 and an elongate body defining a central lumen alongits length. Second tubular member 1420, as illustrated, has a curvatureimparted to it. Also provided are collapsible loops 1430, 1440, whichmay be made from any suitable material. The particular loops illustratedare formed from nitinol. Each loop is defined by a filament that caninclude a stress distribution loop (1432, 1442) formed therein thattraverses 360 degrees or more. Providing a stress distribution loopfacilitates collapse of the loops 1430, 1440 by distributing the bendingstress over a longer effective length of wire. The material from whichloops 1430, 1440 is formed can extend to the proximal end of thecatheter 1400, or may be secured in the distal ends of additionaltubular members (not shown) that are slidably disposed in intermediatetubular member 1450. Loops can be made, for example, from shape memorymaterial such as various nickel titanium alloys.

As illustrated, the subassembly within tubular member 1450 can be bothslidably and rotatably movable with respect to the outer tubular memberof catheter 1400. If desired, each of the subcomponents 1410, 1420, 1430and 1440 may be slidably and rotatably movable with respect to eachother, and the main body of the catheter 1400 as well as theintermediate tubular member 1450.

As illustrated in FIGS. 13A-13C, the embodiment 1400 is illustrated inuse with respect to the structure of a tricuspid valve. In use, afterthe distal end 1402 of catheter 1400 is advanced, for example, to atricuspid valve, the subassembly housed within intermediate tubularmember 1450 is advanced distally out of distal end 1402 of catheter1400, and the distal end 1414 of central tubular member 1410 can bedirected through the center of the tricuspid valve between the leaflets.Next, the two loops 1430, 1440 are deployed and advanced under theleaflet against the center of each leaflet by the valve annulus. Thispermits tubular member 1420 to be positioned at the center of the thirdleaflet by the annulus. At this time, any desired instrument, such as acutting wire or piercing instrument can be advanced through the leafletat its edge by the annulus, such as to advance a electrosurgical cuttingwire through the leaflet, permitting the cutting wire to be draggedradially inwardly through the leaflet to cut the leaflet in half. Inaccordance with a further example, a suture can be anchored bysubassembly component 1420. The suture can then be used as a guide railfor delivering a prosthesis to be implanted over the leaflet, with ourwithout cutting it in half first. It will be appreciated that catheter1400 can be used in many different types of procedures and that theseillustrations are only examples.

The devices and methods disclosed herein can be used for otherprocedures in an as-is condition, or can be modified as needed to suitthe particular procedure. In view of the many possible embodiments towhich the principles of this disclosure may be applied, it should berecognized that the illustrated embodiments are only preferred examplesof the disclosure and should not be taken as limiting the scope of thedisclosure. Each and every patent and patent application referencedherein is expressly incorporated by reference herein in its entirety forany purpose whatsoever.

What is claimed is:
 1. An elongate catheter having a proximal end and adistal end comprising: a) an elongate tubular main body having aproximal end, a distal end, and defining at least one elongate passagetherethrough, the elongate tubular main body defining a longitudinalaxis along its length; b) a first elongate inner body having a proximalend and a distal end that is slidably disposed within the at least oneelongate passage of the elongate tubular main body, the distal end ofthe first inner elongate body being configured to curl away from thelongitudinal axis in a proximal direction when the first elongate innerbody is advanced distally with respect to the main body; and c) a secondelongate inner body having a proximal end and a distal end that isslidably disposed within the at least one elongate passage of theelongate tubular main body, and slidably disposed with respect to thefirst inner body, the distal end of the second inner elongate body beingconfigured to curl away from the longitudinal axis toward the deployedproximally oriented distal end of the first elongate inner body when thesecond elongate inner body is advanced distally with respect to the mainbody.
 2. The elongate catheter of claim 1, wherein each of the firstelongate inner body and second elongate inner body each define a lumenalong their respective lengths, and further wherein the lumen of thesecond elongate inner body includes a movable body slidably disposedtherein having a distal end.
 3. The elongate catheter of claim 2,wherein the movable body includes a guidewire, and further wherein thelumen of the first elongate inner body includes a snare catheterconfigured to be deployed from the distal end of the first elongateinner body to capture the guidewire when the guidewire is deployed fromthe distal end of the second elongate inner body.
 4. The elongatecatheter of claim 2, wherein the movable body includes a guidewirehaving an electrically conductive core wire surrounded by a jacket madefrom dielectric material.
 5. The elongate catheter of claim 4, whereinthe jacket is removed from a portion of the core wire to expose aportion of the core wire.
 6. The elongate catheter of claim 4, whereinthe core wire is surrounded by a first insulating layer, the firstinsulating layer is surrounded by a second electrical conductor, and thesecond electrical conductor is surrounded by an outer insulating layer,wherein the outer insulating layer is removed to expose a portion of thesecond electrical conductor to define an exposed portion of the secondelectrical conductor.
 7. The elongate catheter of claim 6, wherein thesecond electrical conductor is formed from an electrically conductivetube.
 8. The elongate catheter of claim 7, wherein the electricallyconductive tube is defined by a tubular body that in turn defines atleast one opening therethrough.
 9. The elongate catheter of claim 7,wherein the at least one opening is spiral shaped and winds around thefirst insulating layer.
 10. The elongate catheter of claim 7, whereinthe at least one opening and the tubular body define a plurality ofarticulating segments.
 11. The elongate catheter of claim 6, wherein thecore wire
 12. An electrosurgical system including a radio frequencypower supply operably coupled to electrically conductive core wire ofthe elongate catheter of claim
 5. 13. An electrosurgical systemincluding a radio frequency power supply operably coupled to theelectrically conductive core wire and to the second electrical conductorof the elongate catheter of claim
 6. 14. The elongate catheter of claim3, wherein the distal end of the movable body is configured to penetratea target tissue region prior to passing into the lumen of the firstelongate inner body.
 15. The elongate catheter of claim 14, wherein themovable body includes a dart passer that is configured to advance a darthaving a suture attached thereto out of the distal end of the secondelongate inner body and into a receiving cuff disposed in the lumen ofthe first elongate inner body.
 16. The elongate catheter of claim 15,wherein the receiving cuff is attached to a filament that passes throughthe lumen of the first elongate inner body.
 17. The elongate catheter ofclaim 1, wherein the rotational position of the first elongate innerbody is fixed with respect to the rotational position of the secondelongate inner body.
 18. The elongate catheter of claim 1, furthercomprising: a) a third elongate inner body having a proximal end and adistal end that is slidably disposed within the at least one elongatepassage of the elongate tubular main body, the distal end of the thirdinner elongate body being configured to curl away from the longitudinalaxis in a proximal direction when the third elongate inner body isadvanced distally with respect to the main body; and b) a fourthelongate inner body having a proximal end and a distal end that isslidably disposed within the at least one elongate passage of theelongate tubular main body, and slidably disposed with respect to thethird inner body, the distal end of the fourth inner elongate body beingconfigured to curl away from the longitudinal axis toward the proximallyoriented distal end of the third elongate inner body when the fourthelongate inner body is advanced distally with respect to the main body.19. The elongate catheter of claim 18, wherein each of the thirdelongate inner body and fourth elongate inner body define a lumen alongtheir lengths, and further wherein the lumen of the fourth elongateinner body includes a second movable body slidably disposed thereinhaving a distal end that is configured to be received by the lumen ofthe third elongate inner body at the proximally facing distal end of thethird elongate inner body.
 20. A method, comprising: a) providing theelectrosurgical system of claim 12; b) deploying the distal end of thecatheter into a patient's vasculature to a target location proximate thepatient's valve; c) deploying the first elongate inner body so that thedistal end of the first elongate inner body curls around the edge of thepatient's valve leaflet; d) deploying the second elongate inner body sothat the distal end of the second elongate inner body bends toward thedistal end of the first elongate inner body; e) directing the guidewireout of the distal end of the second elongate inner body, through thepatient's valve leaflet, and into the lumen of the first elongate innerbody; and f) advancing the guidewire until the exposed portion of thecore wire or second conductor is located in a gap defined between thedistal end of the first elongate inner body and the distal end of thesecond elongate inner body that coincides with the valve leaflet,wherein the exposed portion of the core wire is facing in a proximaldirection; g) energizing the power supply of the electrosurgical system;and h) advancing the exposed portion of the core wire or secondconductor through at least a portion of the valve leaflet to effectuatea cut in the valve leaflet.